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Technical articles on pharmaceutical engineering.

Practical notes on GMP, cleanrooms, HVAC, validation and project delivery, intended for facility owners and project teams.

In preparation

Our knowledge hub is in preparation. The topics below are planned articles, not published content.

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Topics 06

  • 01Cleanrooms

    In preparation

    Designing pressure cascades that survive commissioning

    This article will examine how pressure cascades for cleanroom suites are defined at concept stage: differential pressure targets between cleanliness grades, airlock arrangements, door leakage and room tightness. It will also look at why a cascade that exists only on drawings can be lost during air balancing.

  • 02Validation

    In preparation

    Why URS quality decides validation effort

    This article will examine how the clarity, testability and traceability of a User Requirements Specification (URS) set the scope of DQ, IQ, OQ and PQ. It will also show how vague or unmeasurable requirements turn into rework, deviations and longer test protocols.

  • 03GMP

    In preparation

    Flow logic first: personnel and material routes in early layouts

    This article will examine how personnel, material, product and waste flows are mapped at concept stage: gowning sequences, airlock placement, and separation of clean and return routes. It will also cover why these decisions are hard to reverse once structure and HVAC zoning are built around the layout.

  • 04HVAC

    In preparation

    HVAC zoning decisions that set energy use and compliance

    This article will examine how grouping rooms onto AHUs by cleanliness grade, product exposure and operating schedule affects air change rates, HEPA filter counts, recirculation versus once-through air, and energy load. It will also identify where these choices carry compliance consequences.

  • 05Project Management

    In preparation

    Planning CQV from day one, not at handover

    This article will examine how an integrated commissioning, qualification and validation (CQV) approach is set up at project start: the validation master plan (VMP), system boundaries, risk-based test scope, and FAT/SAT records structured so qualification can rely on them instead of repeating the tests.

  • 06Facility Planning

    In preparation

    What sets CAPEX before the first drawing

    This article will examine the feasibility decisions that shape the capital cost of a new pharmaceutical plant: product portfolio and dosage forms, capacity and shift assumptions, cleanroom area and grade, PW, WFI and clean steam generation, and phasing for future expansion.

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